Shanghai United Imaging Healthcare Co., Ltd.

Complete recall history across all FDA and CPSC categories — 21 total recalls

Shanghai United Imaging Healthcare Co., Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (21)

FDA medical device enforcement actions by Shanghai United Imaging Healthcare Co., Ltd.

Date Product Reason Class
Mar 1, 2023 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... Due to a software issue where the process of patient scanning, the scatter co... Class II
May 30, 2022 Positron Emission Tomography and Computed Tomography System, Model: uMI 550 The wireless VSM module of a mobile PET/CT system, operating in an environmen... Class II
Aug 2, 2021 uMI 550 System - Product Usage: intended to be operated by qualified healthca... The EXAM acquisition workflow could occasionally freeze after canceling the P... Class II
Aug 2, 2021 uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified... The EXAM acquisition workflow could occasionally freeze after canceling the P... Class II
Jan 25, 2021 Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01)... There is a potential for the X-Ray tube head (Touch screen interface) to per... Class II
Aug 5, 2020 Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 0697157683101... A potential issue of an incorrect CT scan delay timer to be displayed on the ... Class II
Aug 5, 2020 Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 0697157683103... A potential issue of an incorrect CT scan delay timer to be displayed on the ... Class II
Aug 5, 2020 Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 0697157683104... A potential issue of an incorrect CT scan delay timer to be displayed on the ... Class II
Aug 5, 2020 Positron Emission Tomography and Computed Tomography System, Model uMI 550, R... A potential issue of an incorrect CT scan delay timer to be displayed on the ... Class II
Jul 16, 2020 uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is inte... 1) Service function problem may cause false marking of a bad channel resultin... Class II
Jul 16, 2020 uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is in... 1) 1) Potential intermittent issue may cause image data problems, may lead to... Class II
Jun 20, 2020 Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 0697157... The metal edge overlap of the mylar strip in the gantry was uneven, which may... Class II
Jun 20, 2020 Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 0697157... The metal edge overlap of the mylar strip in the gantry was uneven, which may... Class II
Jun 20, 2020 Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 0697157... The metal edge overlap of the mylar strip in the gantry was uneven, which may... Class II
May 23, 2020 Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 In... Two issues were identified with the computed tomography x-ray system includin... Class II
May 8, 2020 uCT 530 Computed Tomography X-Ray System Two issues were identified with the computed tomography x-ray system includin... Class II
May 8, 2020 uCT 760 System, Computed Tomography X-ray System Two issues were identified with the computed tomography x-ray system includi... Class II
Mar 26, 2020 Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... In affected software version, of Positron emission tomography and computed to... Class II
Feb 27, 2020 uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to u... Two issues were identified with the stationary x-ray system. 1. Some position... Class II
Aug 26, 2019 Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, w... Potential sporadic software bugs in R001.3.0.0.750505 software version may ca... Class II
Jul 30, 2019 Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h X-ray imaging system positioning image and protocol label is reversed for Fle... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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